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Transcranial Alternating Current Stimulation for Hand Function Recovery

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
tACS
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
  • MCP and PIP finger joints can be extended to 180° passively;
  • Sufficient cognition to follow the experimental instructions

Exclusion Criteria:

  • Severe hand spasticity or hand deformity;
  • History of alcohol or drug abuse or epilepsy;
  • Bilateral brain infarcts;
  • Severe cognitive deficits;
  • Comprehensive aphasia;
  • Contraindications to tACS and MRI

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

subject-specific tACS

standard tACS

Sham tACS

Arm Description

Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency

Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency

The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect

Outcomes

Primary Outcome Measures

Magnetic resonance imaging
Structural and functional MRI

Secondary Outcome Measures

Action Research Arm Test (ARAT)
The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
Fugl-Meyer Assessment (Upper Extremity)
The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.
Wolf Motor Function Test (WMFT)
The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).

Full Information

First Posted
November 17, 2020
Last Updated
November 17, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04638192
Brief Title
Transcranial Alternating Current Stimulation for Hand Function Recovery
Official Title
Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subject-specific tACS
Arm Type
Experimental
Arm Description
Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency
Arm Title
standard tACS
Arm Type
Experimental
Arm Description
Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency
Arm Title
Sham tACS
Arm Type
Sham Comparator
Arm Description
The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect
Intervention Type
Device
Intervention Name(s)
tACS
Intervention Description
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Primary Outcome Measure Information:
Title
Magnetic resonance imaging
Description
Structural and functional MRI
Time Frame
3-month after the 10th session training
Secondary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
Time Frame
3-month after the 10th session training
Title
Fugl-Meyer Assessment (Upper Extremity)
Description
The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.
Time Frame
3-month after the 10th session training
Title
Wolf Motor Function Test (WMFT)
Description
The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).
Time Frame
3-month after the 10th session training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months; MCP and PIP finger joints can be extended to 180° passively; Sufficient cognition to follow the experimental instructions Exclusion Criteria: Severe hand spasticity or hand deformity; History of alcohol or drug abuse or epilepsy; Bilateral brain infarcts; Severe cognitive deficits; Comprehensive aphasia; Contraindications to tACS and MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD

12. IPD Sharing Statement

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Transcranial Alternating Current Stimulation for Hand Function Recovery

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